GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clarithromycin for Injection BP 500mg (Bruxian)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clarithromycin for Injection BP 500mg
Composition:
Each vial contains:
Clarithromycin IP…………………500mg
Lactobionic Acid BP………………q.s.
1 Ampoule contains:
Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATIONS:

Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.

DIRECTION OF USE:

Shake vigorously with 10ml of sterile water for injection IP for 2-3 minutes to get clear solution before administration.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.
Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store below 25°C. Protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Refer pack insert for further information.
DOSAGE: As directed by Physician.

Clarithromycin for Injection BP 500mg Technical Specification:

Product Name:Clarithromycin for Injection BP
Brand Name:Bruxian
Strength:500mg
Dosage Form:Lyophilized
Dry Powder for Solution for Injection/Infusion
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antibiotic (Macrolide)
Indication: Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.
Storage:Store below 25°C. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Clarithromycin for Injection BP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clarithromycin for Injection BP 500mg
    Composition:
    Each vial contains:
    Clarithromycin IP…………………500mg
    Lactobionic Acid BP………………q.s.
    1 Ampoule contains:
    Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATION:

Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.

DIRECTION OF USE:

Shake vigorously with 10ml of sterile water for injection IP for 2-3 minutes to get clear solution before administration.

CAUTION AND SCHEDULE:

CAUTION: Not to be used if the reconstituted solution contains any visible particles.

The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.

Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

KEEP OUT OF REACH OF CHILDREN

Refer pack insert for further information.

DOSAGE: As directed by Physician.

Why Taj Pharmaceuticals?

When it comes to Clarithromycin for Injection BP, Taj Pharmaceuticals is the name you can trust. We are dedicated to producing pharmaceuticals that meet stringent international standards, ensuring the safety and efficacy of our products. Our state-of-the-art manufacturing facilities and rigorous quality control processes guarantee that you receive pharmaceuticals of the highest quality. At Taj Pharmaceuticals, we prioritize your well-being. Our Clarithromycin for Injection BP is meticulously crafted to provide effective treatment options for various infections. Whether you’re a healthcare professional looking for reliable medication or a patient seeking the best care, our commitment to excellence sets us apart. Explore our range of pharmaceutical solutions and experience the assurance that comes with Taj Pharmaceuticals. Your health is our priority, and we’re here to serve you.

What is Clarithromycin for Injection BP and its use?

Clarithromycin for Injection BP is a pharmaceutical product that contains the active ingredient clarithromycin. Clarithromycin is a macrolide antibiotic that is used to treat various bacterial infections. When formulated as an injectable medication, it is typically used in situations where oral administration is not feasible or in cases where a more rapid onset of action is required.

Here are some common uses for Clarithromycin for Injection BP:

  • Severe Bacterial Infections: It is often prescribed for serious bacterial infections such as pneumonia, skin and soft tissue infections, and respiratory tract infections caused by susceptible bacteria.
  • Treatment of Helicobacter pylori Infections: Clarithromycin is sometimes used in combination with other antibiotics to treat Helicobacter pylori infections in the stomach, which can lead to conditions like gastritis and peptic ulcers.
  • Prevention and Treatment of Mycobacterial Infections: Clarithromycin may be used in combination with other drugs for the prevention and treatment of Mycobacterium avium complex (MAC) infections in individuals with compromised immune systems, such as those with HIV/AIDS.
  • Other Infections: In some cases, it may be prescribed for other types of bacterial infections as deemed appropriate by a healthcare professional.

As with any medication, it is essential to follow the prescribed dosing regimen and complete the entire course of treatment to ensure the most effective results and to minimize the development of antibiotic resistance. Additionally, patients should be aware of potential side effects and consult their healthcare provider if they experience any adverse reactions while taking Clarithromycin for Injection BP.

How Does Clarithromycin for Injection BP work?

Clarithromycin for Injection BP contains the active ingredient clarithromycin, which is a macrolide antibiotic. Clarithromycin works by inhibiting the growth and multiplication of bacteria, ultimately leading to their destruction. Here’s how it works:

  • Inhibition of Protein Synthesis: Clarithromycin interferes with bacterial protein synthesis, a crucial process for bacterial growth and replication. It does this by binding to a part of the bacterial ribosome called the 50S subunit. This binding prevents the ribosome from synthesizing new proteins necessary for the bacteria’s survival and reproduction.
  • Blocking RNA Transcription: Clarithromycin also inhibits the transcription of bacterial RNA (ribonucleic acid), further disrupting the bacterial cell’s ability to produce essential components.
  • Bacteriostatic or Bactericidal: Clarithromycin can exhibit both bacteriostatic and bactericidal effects depending on the concentration and susceptibility of the specific bacteria being targeted. In some cases, it may slow down bacterial growth (bacteriostatic), while in others, it can directly kill the bacteria (bactericidal).
  • Wide Spectrum of Activity: Clarithromycin is effective against a broad spectrum of bacteria, including both Gram-positive and some Gram-negative bacteria. It is particularly useful in treating respiratory tract infections, skin and soft tissue infections, and various other bacterial infections.
  • Treatment of Chronic Infections: Clarithromycin is also used to treat certain chronic bacterial infections, such as those caused by Mycobacterium avium complex (MAC). In these cases, it is often part of a combination therapy with other antibiotics.

Benefits of Clarithromycin for Injection BP:

  • Effective Treatment: Clarithromycin for Injection BP is effective against a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, and certain gastrointestinal infections. It is prescribed when a rapid and reliable response is needed.
  • Helicobacter pylori Eradication: Clarithromycin is often used as part of combination therapy to eradicate Helicobacter pylori bacteria, which can cause gastritis and peptic ulcers.
  • Mycobacterial Infections: It is valuable in the prevention and treatment of Mycobacterium avium complex (MAC) infections, which commonly affect individuals with compromised immune systems, such as those with HIV/AIDS.
  • Broad Spectrum: Clarithromycin exhibits a broad spectrum of activity against both Gram-positive and some Gram-negative bacteria, making it a versatile antibiotic.
  • Intravenous Administration: The injectable form allows for precise dosing and is particularly useful in cases where the patient cannot take oral medications.

Side Effects of Clarithromycin for Injection BP:

  • Gastrointestinal Disturbances: Common side effects include nausea, vomiting, diarrhea, and abdominal discomfort. Taking the medication with food can help alleviate some of these symptoms.
  • Alteration of Taste: Some individuals may experience a metallic or altered taste while taking clarithromycin.
  • Liver Function: Clarithromycin can affect liver function in some individuals, leading to elevated liver enzymes. This is usually reversible upon discontinuation of the medication.
  • Allergic Reactions: Allergic reactions to clarithromycin are rare but can include rash, itching, swelling, severe dizziness, and difficulty breathing. Seek immediate medical attention if you experience any of these symptoms.
  • Cardiac Effects: Clarithromycin has been associated with QT interval prolongation, which can increase the risk of abnormal heart rhythms. It should be used cautiously in patients with a history of heart problems.
  • Drug Interactions: Clarithromycin can interact with various medications, including some statins, antiarrhythmics, and anticoagulants. It’s crucial to inform your healthcare provider about all medications you are taking to avoid potential interactions.
  • Antibiotic Resistance: Like all antibiotics, overuse or misuse of clarithromycin can contribute to the development of antibiotic-resistant bacteria.
  • Clostridium difficile Infection: Prolonged use of antibiotics like clarithromycin can increase the risk of Clostridium difficile-associated diarrhea, which can be severe.

Frequently asked questions about Clarithromycin for Injection BP

Certainly! Here are some frequently asked questions (FAQs) about Clarithromycin for Injection BP:

  1. What is Clarithromycin for Injection BP used for?

Clarithromycin for Injection BP is an antibiotic used to treat various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and Helicobacter pylori infections.

  1. How is Clarithromycin for Injection BP administered?

It is typically administered intravenously (IV) by a healthcare professional in a clinical setting. The dosage and duration of treatment depend on the specific infection and the patient’s condition.

  1. What should I do if I miss a dose of Clarithromycin for Injection BP?

If you miss a dose, it’s essential to consult your healthcare provider. They will determine whether a makeup dose is necessary and how to proceed with your treatment.

  1. What are the common side effects of Clarithromycin for Injection BP?

Common side effects may include nausea, vomiting, diarrhea, abdominal discomfort, and altered taste. Inform your healthcare provider if you experience any side effects.

  1. Are there any serious side effects or allergic reactions to watch out for?

Serious side effects are rare but can include severe allergic reactions, liver problems, and cardiac effects. Seek immediate medical attention if you experience rash, itching, swelling, severe dizziness, or difficulty breathing.

  1. Can Clarithromycin for Injection BP interact with other medications?

Yes, it can interact with certain medications, including some statins, antiarrhythmics, and anticoagulants. Always inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

  1. How long should I take Clarithromycin for Injection BP?

The duration of treatment varies depending on the type and severity of the infection. It’s crucial to complete the full course of treatment as prescribed by your healthcare provider, even if you start feeling better.

  1. Can I consume alcohol while taking Clarithromycin for Injection BP?

It is generally recommended to avoid alcohol while taking antibiotics, as it can potentially interact with the medication and increase the risk of side effects.

  1. Is Clarithromycin for Injection BP safe during pregnancy and breastfeeding?

Clarithromycin should only be used during pregnancy or breastfeeding if the potential benefits outweigh the risks. Consult your healthcare provider for guidance if you are pregnant or breastfeeding.

  1. Can Clarithromycin for Injection BP lead to antibiotic resistance?

Like all antibiotics, overuse or misuse of Clarithromycin for Injection BP can contribute to antibiotic resistance. It should only be used as prescribed by a healthcare professional for bacterial infections.

As Clarithromycin for Injection BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Clarithromycin for Injection BP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Clarithromycin for Injection BP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Clarithromycin for Injection BP, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274